| POSITION TITLE |
Research Compliance, Risk and Education Manager |
| DEPARTMENT |
Lunenfeld-Tanenbaum Research Institute |
| EMPLOYMENT TYPE |
Regular Full Time |
| HOURS OF WORK |
37.5 hours per week |
| EMPLOYEE GROUP |
Non Union |
| REPORTS TO |
Deputy Director - Clinical Research |
Position Description
About Us: The Lunenfeld-Tanenbaum Research Institute at Sinai Health, a University of Toronto affiliated research centre, is one of the world's leading centres in biomedical research. With ground-breaking discoveries in research areas such as diabetes, genetic disorders, cancer and women’s and infants’ health, the Institute is committed to excellence in health research and the training of young investigators. Strong partnerships with the clinical programs of Mount Sinai Hospital and Hennick Bridgepoint Hospital ensure that scientific knowledge is used to promote human health. Your significant contributions will assist in improving our clinical research.
Position Overview: We are seeking an experienced and strategic-minded individual to join our team as a Research Compliance, Risk and Education Manager. In this pivotal role, you will manage all aspects of clinical research compliance and educational initiatives within our institution. Reporting to the Deputy Director of Clinical Research, Sinai Health, you will play a key role in ensuring adherence to regulations, policies, and ethical standards, while also promoting awareness and understanding among our staff and collaborators.
Key Responsibilities:
1. Quality Assurance and Compliance:
• Lead efforts to monitor and enforce compliance with applicable regulations, guidelines, and institutional policies governing research activities.
• Maintain up-to-date knowledge of relevant Health Canada regulations, guidelines and industry standards.
2. Policy Development:
• Drive the development and revision of institutional policies related to research integrity, compliance, and data management, staying abreast of regulatory changes and best practices.
3. Training and Education:
• Develop and implement training programs and materials on research compliance topics for researchers, staff, and stakeholders.
• Provide ongoing education and updates regarding changes in regulations and best practices.
• Assist in the development and review of research protocols, informed consent forms, and other regulatory documents.
4. Audit and Monitoring:
• Conduct regular audits and assessments to evaluate compliance with research protocols and Health Canada regulations, identify areas for improvement, and monitor implementation of corrective actions to ensure timely resolution of compliance issues as needed.
• Maintain detailed records of compliance activities, including audits, inspections and training sessions
• Ensure that all research documentation is accurate, complete and accessible for regulatory review as required.
5. Investigations and Reporting:
• Follow institutional policies to manage investigations of alleged research misconduct or non-compliance, ensuring thorough documentation and reporting to internal and external stakeholders.
6. Collaboration:
• Foster collaboration with other departments, including Research Administration, Research Ethics and Risk Management, regulatory agencies, and external partners to promote a culture of research integrity and compliance throughout the institution.
7. Risk Management:
• Identify potential risks to research quality and compliance, maintain a clinical research risk registry and develop mitigation strategies to ensure the organization’s compliance with regulatory requirements.
8. Reporting:
• Submit annual scorecard and progress reports to the VP Research, Enterprise Risk Management, MAC, and other committees as requested.
Qualifications
- Advanced degree (Master’s or higher) in a relevant field (e.g., life sciences, health sciences, nursing, law, ethics).
- 5 years of progressive experience in research integrity, compliance, regulatory affairs, project management or related fields, with demonstrated leadership and managerial capabilities.
- In-depth knowledge of relevant regulations and guidelines, including but not limited to the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS2), the Food and Drugs Act(Canada) and related regulations, the ICH Harmonised Tripartite Good Clinical Practice Consolidated Guideline (ICH-GCP), the Declaration of Helsinki and applicable privacy and data protection laws.
- Expertise in research data management, from technical and/or legal perspectives, preferred.
- Strong communication and interpersonal skills, with the ability to engage and educate diverse stakeholders effectively.
- Ability to work cooperatively in a team-oriented environment.
- Exceptional attention to detail, analytical skills, and problem-solving abilities.
- Proven ability to thrive in a fast-paced environment and effectively manage multiple priorities.
Application Instructions
Please submit
1) cover letter (including contact information for three references)
2) CV
Applications are accepted until Sunday August 11th, 2024 or until a suitable candidate is identified. Applications will only be accepted through Interfolio.
Applications should be submitted via Interfolio at http://apply.interfolio.com/149722
Equal Employment Opportunity Statement
The Lunenfeld-Tanenbaum Research Institute is committed to equity, diversity, and inclusion, and welcomes applications from all qualified individuals, including those from underrepresented communities. We offer a competitive salary and benefits package, as well as opportunities for professional development and growth. If you are passionate about clinical or discovery research and infectious disease and are looking for a challenging and rewarding opportunity, please apply today.
HOSPITAL DIVERSITY STATEMENT
Sinai Health System recognizes that scholars have varying career paths and that career interruptions due to personal circumstances can be part of an excellent academic record. Candidates are encouraged to explain any personal circumstances in order to allow for a fair assessment of their application. Search committee members have been instructed to give careful consideration to, and be sensitive to the impact of, career interruptions in their assessments.
Sinai Health System is strongly committed to diversity within its community and especially welcomes applications from racialized persons / persons of colour, women, Indigenous / Aboriginal People of North America, persons with disabilities, and members of sexual minority groups, and others who may contribute to the further diversification of ideas.
COLLECTION OF EQUITY DATA
As part of your application, you will be asked to complete a brief Diversity Survey directly on the Interfolio site. This form is voluntary and any information directly related to you is confidential and cannot be accessed by the search committee. Results will be aggregated for institutional planning purposes as part of Sinai Health System’s Equity, Diversity and Inclusion initiative.
OTHER INFORMATION RELEVANT TO THE POSITION
In accordance with Institute’s policy and legislated health and safety requirements, employment is conditional upon the verification of credentials, completion of a health review, and demonstrating proof of immunity and vaccination status of vaccine-preventable diseases.
Sinai Health System is a scent-sensitive environment, and all members of the community are expected to refrain from wearing or using scented products while visiting or working at the Institute. We also support a barrier-free workplace supported by the Institute’s accessibility plan, accommodation and disability management policies and procedures. Should you require accommodation at any point during the recruitment process, including accessible job postings, please contact the Lunenfeld-Tanenbaum Human Resources Department via email at kdudas@lunenfeld.ca. All qualified applicants are strongly encouraged to apply; however, in accordance with Canadian immigration requirements, Canadians and permanent residents will be given priority.
In accordance with Institute’s policy and legislated health and safety requirements, employment is conditional upon the verification of credentials, completion of a health review, and demonstrating proof of immunity and vaccination status of vaccine-preventable diseases. All employees and affiliates will follow safe work practices and comply with health and safety policies, procedures, and training. Successful candidates will be required to provide two (2) written reference letters from their former employer(s)/supervisor(s).
To ensure the safety and wellbeing of all our people and patients, Sinai Health has made it a priority to support everyone in getting vaccinated against COVID-19. Consistent with this, our Staff Immunization & Surveillance Policy was recently updated to include the requirement for full vaccination – currently defined as receiving two doses and serving a 14-day waiting period following the second dose – in order to be able to work at Sinai Health. To be compliant with our updated Policy, you are encouraged to provide proof of dual COVID-19 vaccination, as indicated on the Prospective Immunization and Surveillance Policy Information Sheet, in order to be eligible for employment at Sinai Health. If you believe you are one of the very few people who may require an exemption from vaccination, supporting medical information must be submitted to our Occupational Health department, who will review and assess.
We are a fully committed to fairness and equity in employment and our recruitment and selection practices. We encourage applications from Indigenous peoples, people with disabilities, members of sexual minority groups, members of racialized groups, women and any others who may contribute to the further diversification of our Sinai Health community. Accommodation will be provided in all parts of the hiring process as required under our Access for People with Disabilities policy. Applicants need to make their requirements known in advance.
The Lunenfeld-Tanenbaum Research Institute is a scent sensitive environment, and all members of the community are expected to refrain from wearing or using scented products while visiting or working at the Institute. We also support a barrier-free workplace supported by the Institute’s accessibility plan, accommodation and disability management policies and procedures. Should you require accommodation at any point during the recruitment process, including accessible job postings, please contact the Lunenfeld-Tanenbaum Human Resources Department.
| Posting open until August 11, 2024. We thank all candidates for applying. Only those selected for an interview will be contacted. |
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